UMIN-CTR Clinical Trial

Basic information
Public title	A multicenter retrospective study on the treatment and the prognosis of descending necrotizing mediastinitis
Acronym	A multicenter retrospective study on descending necrotizing mediastinitis
Scientific Title	A multicenter retrospective study on the treatment and the prognosis of descending necrotizing mediastinitis
Scientific Title:Acronym	A multicenter retrospective study on descending necrotizing mediastinitis
Region	Japan

Condition
Condition	Descending necrotizing mediastinitis
Classification by specialty	Surgery in general Gastrointestinal surgery Chest surgery Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Survey on the clinical practice of descending necrotizing mediastinitis in Japan
Basic objectives2	Others
Basic objectives -Others	evaluation of the postoperative outcomes
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	postoperative 30-day mortality
Key secondary outcomes	postoperative 90-day mortality, 1-year survival rate, duration of mechanichal ventilation, postoperative hospital stay.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Descending necrotizing mediastinitis treated in JBES/JACS hospitals from January 2012 to December 2016.
Key exclusion criteria	Patients who refused to participate in the study.
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Kenji, Yoshimasa Middle name Last name Sugio, Maniwa
Organization	Oita University Kobe University
Division name	Department of Thoracic and Breast Surgery
Zip code	879-5593
Address	1-1, Idaigaoka, Hasama-cho, Yufu-shi Oita 879-5593, Japan
TEL	097-586-5854
Email	geka2@oita-u.ac.jp

Public contact
Name of contact person	1st name Tatsuro Middle name Last name Okamoto
Organization	Oita University
Division name	Department of Thoracic and Breast Surgery
Zip code	879-5593
Address	1-1, Idaigaoka, Hasama-cho, Yufu-shi Oita 879-5593, Japan
TEL	097-586-5854
Homepage URL
Email	jbes1703-jacs1806@oita-u.ac.jp

Sponsor
Institute	Oita University, Department of Thoracic and Breast Surgery
Institute
Department

Funding Source
Organization	The Japan Broncho-eshophagological Society
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kobe University, Department of General Thoracic Surgery
Name of secondary funder(s)	The Japanese Association for Chest Surgery

IRB Contact (For public release)
Organization	The institutional review boards of Oita University
Address	1-1, Idaigaoka, Hasama-cho, Yufu-shi, Oita 879-5593, Japan
Tel	097-586-5125
Email	rinrikenkyu@oita-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 12 Month 20 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2018 Year 01 Month 29 Day
Date of IRB	2018 Year 04 Month 16 Day
Anticipated trial start date	2019 Year 03 Month 31 Day
Last follow-up date	2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2020 Year 03 Month 31 Day

Other
Other related information	Retrospective observational study using a questionnair form

Management information
Registered date	2018 Year 12 Month 20 Day
Last modified on	2019 Year 12 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040201